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Completed

NCT Number: NCT02412449

Relative Bioavailability of Two Formulations of AKB-6548 and the Food Effect of a New Tablet in Healthy Adult Subjects

The primary purpose of this study is to compare the PK parameters of a single dose of a test tablet formulation of AKB-6548 relative to a single dose of the reference AKB-6548 tablet formulation, both treatments administered without food, and to compare the PK parameters of the test tablet formulation given under fed and fasted conditions.

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Key information

Conditions

Healthy Anemia Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kalamazoo, Michigan, 49007, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male and female subjects between 18 and 55 years of age, inclusive, and with a body mass index between 18 and 30 kg/m2, inclusive.

Exclusion criteria

  • Current or past history of cardiovascular, cerebrovascular, pulmonary, renal or liver disease.
  • Positive serology results for HBsAg, HCV, and HIV at Screening.
  • Significant renal impairment as evidenced by an estimated glomerular filtration rate (eGFR) of <65 mL/min
  • Known active cancer (except non-melanoma skin cancer) or history of chemotherapy use within the previous 24 months.
  • Current or past history of gastric or duodenal ulcers or other diseases of the GI tract (including gastric bypass surgeries) that could interfere with absorption of study drug.
  • Subjects with a known history of smoking and/or have used nicotine or nicotine-containing products within the past 6 months.

Treatment and study plan

AKB-6548 tablet, reference formulation given in the fasted state

Drug

AKB-6548 tablet, test formulation given in the fasted state.

Drug

AKB-6548 tablet, test formulation given in the fed state

Drug

Primary outcomes

  1. Bioavailability endpoints: Area under the plasma concentration-time curve from 0 to last quantifiable concentration (AUC 0-t) of AKB-6548

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

  2. Bioavailability endpoints: Area under the concentration time curve from time 0 to infinity (AUC 0-inf) of AKB-6548

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

  3. Bioavailability endpoints: Maximum observed plasma concentration (Cmax) of AKB-6548

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

  4. Food Effect Endpoint: AKB-6548 AUC 0-t for the fed versus fasted administration of AKB-6548 tablets

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

  5. Food Effect Endpoint: AKB-6548 AUC 0-inf for the fed versus fasted administration of AKB-6548 tablets

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

  6. Food Effect Endpoint: AKB-6548 Cmax for the fed versus fasted administration of AKB-6548 tablets

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

Secondary outcomes

  1. PK Parameters of AKB-6548: Maximum observed plasma concentration (Cmax)

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

  2. PK Parameters of AKB-6548: Time to reach Cmax (Tmax)

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

  3. PK Parameters of AKB-6548: Terminal elimination rate constant (λz)

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

  4. PK Parameters of AKB-6548: Terminal elimination half-life (t1/2)

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

  5. PK Parameters of AKB-6548: Area under the plasma concentration-time curve from 0 to last quantifiable concentration (AUC 0-t)

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

  6. PK Parameters of AKB-6548: AUC from time 0 to infinity (AUC 0-inf)

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

  7. AKB-6548: Apparent oral clearance (CL/F)

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

  8. AKB-6548: Apparent volume of distribution during the terminal phase (Vz/F)

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

Sponsors and collaborators

Lead sponsor

Akebia Therapeutics

Industry

Registry information

Official study title

A Randomized, Open-Label, Single-Dose, Three-Period Crossover Study in Healthy Adults to Assess the Relative Bioavailability of Test and Reference Formulations of AKB-6548 Tablets and to Evaluate the Effect of Food on the Bioavailability of AKB-6548

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 9, 2015
Registry last updated
Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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